Procedure for Operating a Deaerator in Ointment Manufacturing
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/050 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for operating a deaerator during ointment manufacturing. Proper deaeration removes air bubbles, ensures product consistency, and improves product stability.
2. Scope
This SOP applies to all personnel responsible for handling, operating, and maintaining a deaerator in the ointment production process.
3. Responsibilities
- Production Supervisor: Ensures deaeration is performed as per batch requirements.
- Machine Operator: Operates and monitors the deaerator.
- Quality Assurance (QA) Personnel: Verifies air removal efficiency and product uniformity.
- Engineering Technician: Conducts preventive and corrective maintenance on the deaerator.
4. Accountability
The Production and QA Managers are accountable for ensuring that deaeration operations comply with GMP standards and are properly documented.
5. Procedure
5.1 Pre-Operational Checks
- Ensure the deaerator is clean and free from previous batch residues.
- Verify that vacuum pumps and pressure gauges are functional.
- Check for any leaks in the system before operation.
- Ensure the product temperature is within the specified range for deaeration.
5.2 Loading the Product into the Deaerator
- Transfer the pre-mixed ointment into the deaeration chamber.
- Ensure that the filling level does not
exceed the recommended capacity.
Secure all chamber seals to maintain vacuum integrity.
5.3 Deaeration Process
- Start the vacuum pump and gradually increase vacuum pressure.
- Monitor pressure levels to prevent excessive product foaming.
- Maintain vacuum conditions for the specified duration (e.g., 10-20 minutes).
- Ensure uniform removal of air bubbles by observing product clarity.
5.4 Monitoring the Deaeration Cycle
- Check for visible air pockets in the product.
- Verify that the vacuum system maintains stable pressure.
- Record deaeration time, temperature, and pressure in the Deaeration Log.
5.5 Completion of Deaeration
- Gradually release vacuum pressure before opening the chamber.
- Inspect the product for consistency and homogeneity.
- Transfer the deaerated ointment to the next processing stage.
5.6 Cleaning and Shutdown
- Turn off the vacuum pump and disconnect power supply.
- Flush the deaerator with an approved cleaning solution.
- Sanitize all parts and record cleaning details in the Equipment Cleaning Log.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Deaeration Log (Annexure-1)
- Equipment Cleaning Log (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- Equipment Manufacturer Guidelines
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deaeration Log
| Date | Batch Number | Vacuum Pressure (Bar) | Temperature (°C) | Deaeration Time (Min) | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | -0.8 | 40°C | 15 | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | -0.85 | 42°C | 18 | QA Officer |
Annexure-2: Equipment Cleaning Log
| Date | Deaerator ID | Cleaning Agent Used | Sanitization Method | Verified By |
|---|---|---|---|---|
| 01/02/2025 | DA-101 | Sodium Hypochlorite | Rinsed and Dried | QA Head |
| 02/02/2025 | DA-102 | Ethyl Alcohol | Wiped and Flushed | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |